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Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)

NCT01299142 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-02-18

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.

Conditions

Interventions

DRUG

FGI-101-1A6

anti-TSG101 human monoclonal antibody, single dose

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Functional Genetics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-07-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01299142 on ClinicalTrials.gov